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CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small-cell Lung Cancer

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Trial Information

CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.


Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for
biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH)
studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially
labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott
Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The
probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe
signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green
and orange signals or single red signals identified cells with rearranged ALK; 2)
overlapping of red and green signals (yellowish) indicated cells in which ALK was not
rearranged.

FISH-positive samples for ALK rearrangement were defined as having cells with a clearly
separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric)
probe. The higher threshold for loss is necessary because parts of probes can be lost during
sectioning Clinical details of these patients were included in a database. Further results
will be analyzed with the program SPSS17


Inclusion Criteria:



- The only inclusion criterion was the availability of tissue for biomarker studies.

Exclusion Criteria:

- Disease Progression

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

ALK rearragements for the hybritation FISH break apart (LSI-ALK)

Outcome Description:

The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.

Outcome Time Frame:

TWO YEARS

Safety Issue:

No

Principal Investigator

Oscar Arrieta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto de Cancerología

Authority:

Mexico: Federal Commission for Sanitary Risks Protection

Study ID:

INCAN/CC/039/11

NCT ID:

NCT01662635

Start Date:

February 2011

Completion Date:

June 2014

Related Keywords:

  • Non Small-cell Lung Cancer
  • Non-small cell lung cancer.
  • Diagnosis,
  • Adenocarcinoma,
  • ALK,
  • FISH,
  • Protein-tyrosine kinase
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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